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Clinical Trial on Individual Characteristics Affecting Pain Drug Therapy in Neonates (NeoPopGen)

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ClinicalTrials.gov Identifier: NCT02426463
Recruitment Status : Completed
First Posted : April 27, 2015
Last Update Posted : February 4, 2019
Sponsor:
Collaborators:
University of Turku
Helsinki University
Information provided by (Responsible Party):
Turku University Hospital

Brief Summary:

Children differ from adults with respect to growth and development but also immaturity of various pharmacological mechanisms. Dosing schemes in children are usually derived in an empirical manner from clinical trials in adult patient groups. All this poses neonates to an increased risk for therapeutic failure and adverse drug reactions.

Medicinal products studied during this project are among the ones with the highest needs for research in the pediatric intensive care. This project focuses on the necessity to integrate subject's individual characteristics to assist clinical decision-making in drug therapy. The investigators explore the mechanisms defining the dose response in pediatric populations. The results obtained with these studies will help to find safer drug dosing regimens in this delicate patient population.


Condition or disease Intervention/treatment Phase
Critical Illness Drug: propofol Drug: oxycodone Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Individualising Drug Therapy in Neonates Using Pharmacogenomic Profiling, Population Based Modeling and Simulations
Actual Study Start Date : April 20, 2015
Actual Primary Completion Date : February 28, 2017
Actual Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Propofol
Plasma samples and patient data are collected prospectively from 40 neonates who receive propofol as part of their care in the neonatal intensive care unit at the Turku University Hospital, Turku, Finland.
Drug: propofol
Active Comparator: Oxycodone
Plasma samples and patient data are collected prospectively from 40 neonates who receive oxycodone as part of their care in the neonatal intensive care unit at the Turku University Hospital, Turku, Finland.
Drug: oxycodone



Primary Outcome Measures :
  1. Area under the plasma concentration versus time curve (AUC) of propofol and oxycodone. [ Time Frame: 24 hours post-dose. ]
    Primary outcome is to build up a population pharmacometric model to describe pharmacokinetics of propofol and oxycodone based on drug concentrations analyzed from the plasma samples.


Secondary Outcome Measures :
  1. Effect of biometric and genomic covariates on AUC [ Time Frame: 24 hours post-dose ]
    Covariate analysis and simulations to individualize population models

  2. Efficacy of propofol in procedural anesthesia in neonates [ Time Frame: 24 hours ]
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability during procedural anesthesia for intratracheal intubation in neonates

  3. Efficacy of oxycodone as an analgesic in neonates during mechanical ventilation [ Time Frame: 24 hours ]
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability in neonates after oxycodone administration during mechanical ventilation.



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Ages Eligible for Study:   24 Weeks to 40 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Given informed consent by the guardian of an eligible patient.
  • Patient is more than 24 weeks old and has a body weight more than 500 g.
  • Patient needs intensive care treatment based on a clinical decision by a neonatologist and receives propofol or oxycodone on their therapy. Attending neonatologist makes the decision to prescribe propofol for scheduled short procedural sedation or oxycodone for analgesia as well as all other treatment related decisions.

Exclusion Criteria:

  • Eligible patients guardian declines to give informed consent.
  • A previous history of intolerance to the study drugs or to related compounds and additives.
  • History of any kind of drug allergy.
  • Participation in any other studies concomitantly or within one month prior to the entry into this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426463


Locations
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Finland
Department of Paediatrics and Adolescent Medicine, Turku University Hospital
Turku, Finland, 20521
Sponsors and Collaborators
Turku University Hospital
University of Turku
Helsinki University
Investigators
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Principal Investigator: Teijo I Saari, MD, PhD Dept. Anaesthesiology and Intensive Care, University Of Turku

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Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT02426463     History of Changes
Other Study ID Numbers: T65/2015
First Posted: April 27, 2015    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019

Keywords provided by Turku University Hospital:
Neonatal intensive care
need for intratracheal intubation

Additional relevant MeSH terms:
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Oxycodone
Critical Illness
Disease Attributes
Pathologic Processes
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents